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Methylphenidate 10mg Tablets

Manufacturer CARACO Active Ingredient Methylphenidate Tablets(meth il FEN i date) Pronunciation meth il FEN i date
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat narcolepsy.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Not available
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FDA Approved
Aug 1955
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy. It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. It can help improve focus, reduce hyperactivity, and manage sleepiness.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose 30 to 45 minutes before meals. If you take this medication more than once a day, be sure to take your last dose before 6 PM.

Storing and Disposing of Your Medication

Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Store it in a safe and secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, do not take it after 6 PM. If your next scheduled dose is near, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less than directed.
  • Take the immediate-release tablets 30-45 minutes before meals.
  • Avoid taking doses late in the day to prevent sleep problems.
  • Store in a safe place to prevent misuse or abuse.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol consumption, especially with extended-release formulations, as it can lead to rapid release of the drug.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, regular monitoring of height and weight is important.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: For ADHD: 10 mg orally 2 or 3 times daily, preferably 30 to 45 minutes before meals. For Narcolepsy: 10 mg orally 2 or 3 times daily.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 5 mg orally twice daily. Titrate weekly by 5-10 mg/day. Max: 60 mg/day.
Narcolepsy: Initial: 10 mg orally twice daily. Titrate weekly by 10 mg/day. Max: 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD (6 years and older): Initial: 5 mg orally twice daily (before breakfast and lunch). Titrate weekly by 5-10 mg/day. Max: 60 mg/day.
Adolescent: For ADHD: Initial: 5 mg orally twice daily (before breakfast and lunch). Titrate weekly by 5-10 mg/day. Max: 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not well studied. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The precise mechanism of action in ADHD and narcolepsy is not fully understood but is believed to involve the modulation of dopaminergic and noradrenergic neurotransmission in the brain.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30-50%
Tmax: 1-2 hours (for immediate-release tablets)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-3 hours (for immediate-release tablets)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (urine)
Unchanged: Less than 1% of the dose is excreted unchanged in the urine; approximately 90% is excreted as ritalinic acid.
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for immediate-release tablets)
PeakEffect: 1-2 hours (for immediate-release tablets)
DurationOfAction: 3-6 hours (for immediate-release tablets)

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
 Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Severe headache, dizziness, or fainting.
 Joint pain.
Purple patches on the skin or mouth.
 Changes in vision or eye pain, swelling, or redness.
Seizures.
 Shakiness or tremors.
Difficulty controlling body movements.
 Uncontrollable sounds, such as humming, throat clearing, yelling, or making loud noises.
Excessive sweating.
 Restlessness.
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas.
 Numbness, pain, tingling, or cold sensation in hands or feet.
Sores or wounds on fingers or toes.
 Muscle pain or weakness, dark urine, or difficulty urinating.
Changes in sex drive.
 Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor. Seek immediate medical attention if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness.
 Prolonged or painful erections (lasting more than 4 hours) can occur, even when not engaging in sexual activity. If this happens, seek medical help right away to prevent long-term sexual dysfunction.
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations, have been reported. If you or a family member have a history of mental health conditions (e.g., depression, bipolar disorder) or suicidal tendencies, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, or loss of interest in life.
 A potentially life-threatening condition called serotonin syndrome can occur when taking this medication with certain other drugs. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness or headache.
 Drowsiness.
Dry mouth.
 Stomach pain, upset stomach, vomiting, or decreased appetite.
Heartburn.
 Weight loss.
Feeling nervous or excitable.
 Difficulty sleeping.
* Nose or throat irritation.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggression, hostility, or irritability
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Numbness, tingling, or coldness in fingers or toes
  • Unexplained wounds on fingers or toes
  • Prolonged or painful erection (priapism)
  • Blurred vision or other eye problems
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
 Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever had a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
 If you are currently taking any of the following medications:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) drugs
 Natural products
* Vitamins

Your doctor needs this information to ensure it is safe for you to take this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor. In children and teenagers, this medication may affect growth in some cases, and regular growth checks may be necessary. Consult with your doctor to discuss any concerns.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
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Major Interactions

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
  • Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism of anticoagulants, increasing bleeding risk.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of anticonvulsants, increasing serum levels.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism of antidepressants, increasing serum levels and toxicity.
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Moderate Interactions

  • Antihypertensive agents - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., bromocriptine, levodopa) - potential for additive dopaminergic effects.
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Minor Interactions

  • Alcohol - may increase plasma levels of methylphenidate and lead to dose dumping with extended-release formulations.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To identify pre-existing cardiovascular conditions and establish baseline for monitoring stimulant-induced increases.

Timing: Prior to initiation of therapy.

Height and Weight (Pediatric patients)

Rationale: To monitor for potential growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric History and Symptoms

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.

Timing: Prior to initiation of therapy (if indicated).

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age; significant increases should prompt evaluation.

Action Threshold: Sustained increase >10-20 mmHg systolic/diastolic or significant tachycardia.

Height and Weight (Pediatric patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant deviation from expected growth curve.

ADHD Symptoms and Treatment Response

Frequency: Regularly, at each follow-up visit.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms.

Psychiatric Symptoms (e.g., agitation, psychosis, mania, depression, anxiety)

Frequency: Regularly, at each follow-up visit.

Target: Stable or improved mood/behavior.

Action Threshold: Emergence or worsening of psychiatric symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Unexplained wounds on fingers/toes (Raynaud's phenomenon)
  • Numbness or tingling in extremities
  • Persistent priapism (rare)

Special Patient Groups

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Pregnancy

Methylphenidate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Observational studies have not shown an increased risk of major congenital malformations with methylphenidate exposure during the first trimester.

Trimester-Specific Risks:

First Trimester: Limited data suggest no increased risk of major congenital malformations. However, potential for cardiovascular effects (e.g., tachycardia, hypertension) in the mother could indirectly affect fetal perfusion.
Second Trimester: Potential for maternal cardiovascular effects. Monitor fetal growth and well-being.
Third Trimester: Potential for maternal cardiovascular effects. Neonates exposed to amphetamines (a class of stimulants) in utero may experience withdrawal symptoms (e.g., agitation, tremor, poor feeding) after birth. Monitor neonate for signs of withdrawal.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for adverse reactions such as agitation, insomnia, decreased appetite, or poor weight gain.

Infant Risk: Moderate risk (L3). Monitor infant for irritability, poor feeding, and sleep disturbances. Consider using the lowest effective dose and monitoring infant weight and development.
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Pediatric Use

Methylphenidate is approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression). Cardiovascular monitoring is also crucial.

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Geriatric Use

Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular conditions. Monitor blood pressure and heart rate closely.

Clinical Information

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Clinical Pearls

  • Methylphenidate immediate-release (IR) tablets typically have a short duration of action (3-6 hours), requiring multiple daily doses. This can be beneficial for flexible dosing but may lead to 'rebound' effects as the drug wears off.
  • For patients experiencing significant 'rebound' or needing longer duration, consider extended-release formulations of methylphenidate.
  • Always assess for a history of substance abuse, cardiac conditions, and psychiatric disorders (especially bipolar disorder or psychosis) before initiating methylphenidate.
  • Educate patients and caregivers about the potential for abuse and the importance of secure storage.
  • Growth suppression is a concern in pediatric patients; regular monitoring of height and weight is essential. A 'drug holiday' (e.g., during weekends or school breaks) may be considered to mitigate this, but should be discussed with a physician.
  • Cardiovascular monitoring (BP, HR) is critical due to the risk of stimulant-induced increases. Discontinue if significant or persistent increases occur.
  • Psychiatric adverse events, including new-onset psychosis or mania, can occur. Promptly evaluate any new psychiatric symptoms.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Amphetamine/dextroamphetamine, Lisdexamfetamine, Dextroamphetamine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive Behavioral Therapy (CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 30 tablets (10mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.